May 2013

• K-REACH published

Aug 2013

• Public consultation consortium formed
• Consortium members
• Industry: Large(4), Medium(3), Foreign(3), Association(2)
• NGO/Experts : NGO, Consulting firms, Academic experts

Sep 2013

• Commencement of consortium meeting;
• Public comments through various media (forums, associations);

Dec 2013

• Lower decrees being prepared based on the issues discussed by the consortium

Dec 2013

• Prepare lower decrees

Jan 2014

• Begin with legislation process
• Discussions with related ministries

Feb 2014

Establishment of Industry Support Centre

• K-REACH Helpdesk
• online and offline supports including trainings in different regions, manuals, etc.

Feb 2014 ~

Establishment of public and authority organization

• Monitoring and development of support programs, promoting self-management of chemical substances.

Jan 2014 ~

Development of K-REACH support

• Preparation of guidance (registration, risk assessments,  etc.)
• IT system for (annual report, registration assessment,  etc.)
• Promote GLP testing labs in Korea

Oct 2014

Prior notice of substances subject to registrations and their grace period.

K-REACH- article 11

• A chemical substance prescribed by the Presidential Decree can be manufactured or imported without registration. However, companies shall receive a confirmation letter on exemption.

Public hearing results

• Substances for R&D are exempted from registration
• Activities covered: process improvement, reagent, pilot production before mass production
• Allowed to be transported to different sites when transportation and safety management scheme is submitted
• No limits on the quantity. However, the quantity for R&D purposes shall be submitted.

K-REACH-Article 10 & 14

• Any person who intends to manufacture/import a new chemical substance or an existing chemical substance subject to registration in a quantity of 1 ton or more per year shall register the substance prior to manufacture/importation.
•  Information are to be submitted with registration. Information of the manufacturer or the importer, Information that identifies the chemical substance, Use, Classification & labeling, Physical and chemical properties, Hazard, Risk assessment, Guidance data for safe use, other data as prescribed by Environment Ministerial Decree.

Public hearing results

• Simplified registration for new substances with tonnages less than 1 ton per annum;
• After 2020, simplified registration is only available for new substances with tonnages less than 0.1 ton per annum;
• Information required: information of the manufacturer or the importer, information of substance identity, use, and exposure information related to use).
• Extra information may be requested in case where a product may expose to consumers directly or accumulated tonnage exceeds simplified registration criteria.

K-REACH-Article 29 & 30

• Any person who transfers a registered chemical substance or preparation containing it shall generate and provide the transferee with the information specified in the Environment Ministerial Decree, including its registration number, chemical name, hazards, risks, and information for safe use
• Transferring person, on request, shall provide above information on request and vice versa

Public hearing results

• Chemical name, hazard information, restricted uses, information on safe use need to be provided;
• CBIs including compositions and content can be protected;
• Manufacture, import, use and sales quantity may be provided on request.

K-REACH-Article 9 & 10

• Designation of substances subject to registration will consider domestic trade volume and information on hazards and risks of the chemical substance
• Any person who intends to manufacture/import  an existing chemical substance subject to registration may manufacture/import it without registration during the grace period prescribed in the Presidential Decree

Public hearing results

• Will also consider uses and exposure levels
• Substances subject to registration will be designated every 3 years and companies will have 3 years grace period to prepare registration (there will be around 500 substance on the first list)
• Prior notice will be released in 2014 (before the enforcement of K-REACH)

K-REACH-Article 10 & 14

• Any person who intends to manufacture/import a new chemical substance or an existing chemical substance subject to registration in quantity of 1 ton or more per year shall register the substance prior to manufacture/importation;
• A chemical substance prescribed by the Presidential Decree and obtained a confirmation of exemption from registration can be manufactured or imported without registration

Public hearing results

• Impurities and by-products(un-intended/by accidents) are not subject to registration, but they need to be specified in the registration of main substance (like EU REACH);
• Non-isolated intermediates are exempt (like EU REACH); Isolated intermediates are not exempt.
• Low concern polymers are exempted(from registration) with exceptional cases(e.g. cationic) which requires registrations.

K-REACH-Article 14 & 16

• Registrants are required to submit physicochemical properties and hazardous information of substances obtained from testing institutes
• Test data submitted by other registrant can be used if permission from the data owner is acquired.
• Test proposal specifying test conditions and schedule information are allowed for certain endpoints
• Detailed information required for test data are to be specified in Ministerial Decree

Public hearing

• LoA from data owner can be submitted for substances which have been registered under K-REACH (by other registrants)
• Test proposals prepared by domestic testing institutes are accepted
• With proving reliabilities, non-test data (QSAR, read-across) are accepted;
• Substances with no expected hazards will qualify for simplified registration and benefit from reduced data requirements(New!).

K-REACH

Related Provisions (article 20 & 25~28)

• Designation of toxic chemicals, authorization substances, restricted and banned substances will be based on the results of hazardous evaluation and risk assessments

Public hearing

• Designation of Toxic chemicals criteria will be based on Korea GHS
• Detailed information of designation criteria of authorization substances (CMR, etc.)
• Social economy analysis and prior notice will be performed for the  designation of toxic chemical substances.

K-REACH-Article 32

• Manufacturer or importer of products containing toxic chemical substances more than 1 ton per annum are required to submit notification with containing chemical information, composition, uses, etc.
• Products are exempted from notification if chemicals are not released under normal conditions of use and are in solid forms

Public hearing results

• Products are subject to notification if the contents of toxic chemical substances are more than 0.1%;

K-REACH-Article 15~17 & 46

• The state shall support SMEs in regards to registrations and evaluations
• Registration, notification, re-registration, registration/notification exemption application occurs fees

Public hearing results

• Prepare fair and clear criteria for the trades of test data
• Discounted fees for SMEs

K-REACH-Article 15~17 & 46

• K-REACH will be enforced from 1st Jan 2015
• A person who is notified under TCCA is considered as registered under K-REACH (requires notification to MoE that they have been complied with TCCA)

Public hearing results

• Manufacturers or importers of new chemical substances which have been notified under TCCA by someone else are granted with 1~2 year grace period for registration
• Polymers which are granted with exemptions under TCCA but fall under registration criteria under K-REACH are granted with 3~5 year grace period for registration